- Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
- Enroll patients as required by the study sponsor and internal enrollment monitor team
- Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance
- Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
- Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations
- Maintain research charts and/or electronic files for all enrolled patients
- Ensure adequate source documentation is in place for all data reported
- Resolve data queries issued by the sponsor
- Obtain protocol clarifications from the study sponsor and communicate information to the research team
- Schedule and prepare for monitoring visits with sponsors
- Facilitate the request and shipment of archival pathology samples
- Organize and prepare for internal and external audits
- Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
- Maintain and organize study specific regulatory binders
- Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
- Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study
- Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required
- Submit Data and Safety Monitoring Reports
- Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process
- Collect, complete, and submit essential regulatory documents to various regulatory entities
- Participate in monitoring visits and file all monitoring visit correspondence
- Ensure appropriate documentation of delegation and training for all study staff members
- Maintain screening and enrollment logs
- Careful attention to detail
- Good organizational skills
- Ability to follow directions
- Good communication skills
- Computer literacy
- Working knowledge of clinical research protocols
- Ability to demonstrate respect and professionalism for subjects rights and individual needs
- BA/BS degree required
- None
- None
- Duties may be performed in a combination of on-site and remote work setting
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Massachusetts General Hospital(MGH) Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · Under the supervision of the Associate Director, Senior Developer, and other Developers/support personnel, the incumbent will assist with the development and maintenance of complex applications used to support the MGH Cancer Center Protocol ...
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Partners Healthcare System Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized clinical research office that supports clinical resea ...
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Massachusetts General Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking a motivated, detail-oriented individual to join our team as a Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized research office that supports clinical researchers i ...
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Partners Healthcare System Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized clinical research office that supports clinical resea ...
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Partners Healthcare System Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized clinical research office that supports clinical resea ...
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Massachusetts General Hospital Boston, United StatesThe Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized clinical research office that supports clinical researchers in Clinical Research, Research C ...
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Partners Healthcare System Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Pappas Center for Neuro-Oncology at Massachusetts General Hospital is seeking a motivated, conscientious individual to join our team as a Clinical Research Coordinator (CRC). The CRC will work under general supervision of and report to t ...
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Massachusetts General Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Associate/Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized research office that supp ...
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Massachusetts General Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individual to join our team as a Clinical Research Biopsy Coordinator. The Cancer Center Protocol Office is a centralized clinical research office that supports clinical ...
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Massachusetts General Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Data Specialist (CRDS). The Cancer Center Protocol Office is a centralized research office that supports clinical res ...
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Partners Healthcare System Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking a Clinical Research Associate Manager to join our team. The Cancer Center Protocol Office is a centralized clinical research office that supports clinical researchers in all disciplines within the ...
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Massachusetts General Hospital(MGH) Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking a Clinical Research Associate Manager to join our team. The Cancer Center Protocol Office is a centralized clinical research office that supports clinical researchers in all disciplines within th ...
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Clinical Research Coordinator II
2 weeks ago
Beth Israel Lahey Health Boston, United StatesWhen you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Regular · Scheduled Hours: · 40 · Work Shift: · Day (United States of America) · Responsible for screening patients for participation in clinical trials, ...
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Clinical Research Coordinator
2 weeks ago
Beth Israel Lahey Health Boston, United StatesWhen you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Regular · Scheduled Hours: · 40 · Work Shift: · Day (United States of America) · Responsible for screening research subjects for participation in clinica ...
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Clinical Research Coordinator
2 days ago
Beth Israel Lahey Health Boston, United StatesJob Type: Regular · Time Type: Full time · Work Shift: Day (United States of America) · FLSA Status: Non-Exempt · When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Responsible for screening research subjects for par ...
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Clinical Research Coordinator
1 week ago
Beth Israel Lahey Health Boston, United StatesWhen you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Regular · Scheduled Hours: · 40 · Work Shift: · Day (United States of America) · The CardioVascular Institute at BIDMC is seeking a motivated and detail- ...
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Clinical Research Coordinator 1
1 week ago
Beth Israel Lahey Health Boston, United StatesWhen you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Regular · Scheduled Hours: · 40 · Work Shift: · Day (United States of America) · Responsible for screening research subjects for participation in clinica ...
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Per Diem Research Assistant
2 weeks ago
Beth Israel Lahey Health Boston, United StatesWhen you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Per Diem · Scheduled Hours: · 0 · Work Shift: · Day (United States of America) · Responsible for screening research subjects for participation in clinica ...
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Partners Healthcare System Boston, United StatesThe Clinical Research Coordinator I (CRC) for the Orthopaedic Spine Service will be responsible for assisting with the day-to-day clinical research operation. She/he will be responsible for IRB protocol development, candidate screening, clinical evaluation, coordination of patien ...
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Brigham and Women's Hospital Boston, United StatesThe Clinical Research Coordinator II works within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DF/HCC Clinical Trials Office and/or Pa ...
Clinical Research Associate---Cancer Center Protocol Office - Boston, United States - Partners Healthcare System
Description
GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Associate.
The Cancer Center Protocol Office is a centralized research office that supports clinical researchers in all disciplines within the Cancer Center.
Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements.
The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies.
The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting.
The CRA I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact.PRINCIPAL DUTIES AND RESPONSIBILITIES:
The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager:
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
EDUCATION:
EXPERIENCE:
SUPERVISORY RESPONSIBILITY:
WORKING CONDITIONS:
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